A Fundamental Reform of Processes and Deadlines for Notified Bodies

On May 4, 2026, the European Commission adopted Implementing Regulation (EU) 2026/977, which was published in the Official Journal of the EU the very next day. It represents a fundamental procedural reform of the conformity assessment of medical devices under the MDR and IVDR. The stated goal is to harmonize differing interpretations of the regulations and the fragmented practices of notified bodies, increase transparency, and ensure market predictability—all without compromising patient safety, according to the Commission. The regulation, which will take effect on February 25, 2027, responds to a market crisis that has particularly affected small and medium-sized enterprises.

Although the adoption of the MDR and IVDR was originally intended to improve safety, practice has revealed profound shortcomings in the operations of notified bodies. A loose interpretation of the rules led to non-transparent pricing and extreme delays, with certification taking as long as 18 months. Furthermore, bodies artificially prolonged the processes by abusing the suspension of deadlines, thereby slowing down the entire market. In December, the European Commission responded to this crisis with a “two-pronged offensive”: a proposal for a major revision of the MDR/IVDR and, in parallel, this Implementing Regulation. During the consultations, however, the TEAM-NB association intervened in the text and pushed through a compromise adjustment of the unrealistic deadlines.

Significant Changes

The regulation marks a revolution in transparency. Notified entities are now required to issue binding price quotes based on accurate information from the manufacturer, even with regard to the entity’s potential status as a small or medium-sized enterprise. Any increase in estimated costs exceeding 10% must be reported in advance and duly justified. A landmark change is the introduction of strict maximum time limits for the assessment process: 30 days to review the application and sign the contract, 120 days for QMS audits, 90 days for product verification, and 20 days for the final decision and certification. At the same time, the number of possible interruptions to these deadlines is being limited. In addition, entities will be required to publish annual reports on the actual duration of the processes and the associated costs.

The introduction of fixed deadlines effectively means that manufacturers must submit virtually error-free technical documentation right from the initial application. Experts warn that these steps represent a systematic reduction in safeguards and risk that pressure to cut costs will take precedence over patient safety and public health.

Furthermore, the TEAM-NB association itself is highly critical of the major revision of the MDR and IVDR currently under discussion. While the Commission is pushing for a radical acceleration of processes, the abolition of the five-year validity of certificates, and mandatory 50% fee reductions for smaller businesses, TEAM-NB fears for its financial and operational survival. However, the European Commission did not wait for the lengthy approval process for the major revision and, by issuing this implementing regulation, is attempting to compel notified bodies to take corrective action. We shall see to what effect.

Author: Markéta Hrubá